(69 days)
The Arthrex FastThread™ Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tenair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist
The Arthrex FastThread™ Interference Screw is a cannulated, fully threaded, bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter and 20-30 mm in length.
This document is a 510(k) premarket notification for the Arthrex FastThread™ Interference Screw, a medical device used for fixing tissue (ligament or tendon) to bone. It does not describe an AI/ML powered device, therefore the information requested about acceptance criteria and study data related to AI/ML device performance (such as sample size for test/training sets, expert qualifications for ground truth, MRMC studies, or standalone algorithm performance) is not applicable.
The provided text focuses on demonstrating the substantial equivalence of the new Arthrex FastThread™ Interference Screw to a previously cleared predicate device (Arthrex Interference Screw, K071176).
However, I can extract information related to the performance data and the conclusion on substantial equivalence, which serves a similar function to "acceptance criteria" and "proof of meeting criteria" in the context of this 510(k) submission.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Pullout strength at time zero | Statistically equivalent to the predicate device |
| Pullout strength after 16 weeks degradation | Statistically equivalent to the predicate device |
| Insertion performance | Statistically equivalent to the predicate device |
| Pyrogenicity (Bacterial Endotoxin) | Meets pyrogen limit specifications per EP 2.6.14/USP |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study was likely conducted in a laboratory setting for mechanical and biological testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a mechanical and biological testing study, not an AI/ML study requiring expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable; this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable; this is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the pullout and insertion tests, the "ground truth" would be the objective measurements of force and resistance, typically compared against pre-defined engineering specifications or the performance of a predicate device.
- For bacterial endotoxin testing, the "ground truth" is compliance with a recognized standard (EP 2.6.14/USP ).
8. The sample size for the training set:
- Not applicable; this is not an AI-powered device using training data.
9. How the ground truth for the training set was established:
- Not applicable; this is not an AI-powered device.
Study Proving the Device Meets Acceptance Criteria:
The document states: "Pullout testing at time zero and after 16 weeks degradation and insertion testing was conducted to demonstrate that the proposed Arthrex FastThread™ Interference Screw performs statistically equivalent to the predicate. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications."
This indicates that mechanical tests (pullout strength, insertion performance) and a biological test (bacterial endotoxin) were performed. The "acceptance criteria" here are framed in terms of statistical equivalence to the predicate device for mechanical properties and meeting established pyrogen limits for biological safety. The conclusion drawn is that "Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device."
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.